Multi-channel vitals device

ABSTRACT

An integrated vitals device capable of acquiring multiple data streams, allowing for comprehensive measurement of whole health status using a single, compact device. This allows for simplification of traditional healthcare delivery where multiple devices are required for acquisition of vital signs. A sensor stack up, occupying the approximate physical footprint and volume allows this approach to be possible. This application describes how these simultaneous vitals data streams can be acquired using an integrated device with small mass and volume.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application claims the benefit of each of co-pending U.S.provisional application No. 62/154,758, filed on Apr. 30, 2015,co-pending U.S. provisional application No. 62/154,788, also filed onApr. 30, 2015, and co-pending U.S. provisional application No.62/154,967, also filed on Apr. 30, 2015, the entire disclosure of eachof which is incorporated by reference as if set forth in their entiretyherein.

STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT

This work was funded in part via NASA Contract NNX14CJ25P.

TECHNICAL FIELD

The field relates to the development of a novel integrated vitals sensorfor comprehensive and wireless measurement of electrocardiogram (EKG),oxygen saturation (SpO2), heart rate, respiratory rate, blood pressure,and core body temperature. The sensor utilizes unique packaging andintegration to achieve measurement of important vital signs using asingle, small package sensor.

BACKGROUND

The wireless monitoring of vital signs is particularly important forremote health monitoring. This allows patients and consumers to monitortheir health with greater flexibility than traditional wired approaches.Recently, with the advent of Bluetooth technology, and in particular,Bluetooth Low Energy (BLE), remote sensing has gained more capabilities.This allows devices to be paired with apps on smartphones. These basictechnologies have inspired the new wave of wearables for health andfitness. There does not exist, however, a comprehensive technology thatmeasures important medical vital signs in a continuous manner. Mostapproaches fail to measure one or more of the important vital signs.

EKG is conventionally measured by the use of 12-lead systems in thehospital. For portability, the Holter monitor is utilized to capturecardiac events over the course of an extended time period.Unfortunately, this approach is difficult because it requires theattachment of wires to various parts of the body and then a sizablebattery-powered unit that is worn on the belt. After a certain timeperiod of recording, data is transmitted over the telephone. This methodis still in use today and is a means to capture cardiac events frompatients. The size and weight of the unit makes it cumbersome for mostusers.

Measurement of pulse oximetry is done using a finger probe. The probesshine a red light and an infrared light through the finger and thenmeasures the change in absorbance from beat-to-beat. The relative ratioof the absorbance is presented as the ratio of ratios, the ratio of theAC signal of red over the DC signal of red over the AC signal ofinfrared over the DC signal of infrared. This ratio method corrects forany DC drift in the system and allows the ratios of the two wavelengthsto be measured accurately. At 660 nm, deoxygenated hemoglobin Hb absorbsmore than oxygenated hemoglobin HbO2. At 910 nm infrared, the HbO2absorbs more than the Hb. The finger probes can be worn briefly, butinterfere with daily life and tasks.

It is easy to measure skin temperature in a continuous manner or tomeasure core temperature in a single measurement. However, continuouscore body temperature measurement is challenging. This would require aninternal probe in the gastrointestinal tract, a catheter, or some otherinternal probe. These are invasive and cannot be utilized in routinesettings for consumers and patients. Core body temperature fluctuationscan happen quickly, signaling worsening infection or some other processthat needs medical attention fast.

Heart rate and respiratory rate are important physiological parametersthat give significant insight into health and wellness. Heart rate isreadily derived from both photoplethysmograph (PPG) and EKG signals.Weak EKG or PPG signals can lead to inaccuracies and ideally, the heartrate and respiratory rates can be redundantly analyzed from both datatraces.

Blood pressure measurements are currently performed utilizing cuff-basedapproaches, typically a sphygmomanometer that is applied around the arm.Inflation of the cuff using a rubber bulb occludes blood flow allowingfor determination of blood pressure. Both the systolic and diastolicblood pressures can be determined by listening to the Korotkoff soundsgenerated during this process. The sounds are heard using a stethoscopeand interpreted by a skilled medical professional. This approach givesonly, individual and not continuous blood pressure readings.

There are significant challenges that need to be overcome in order tohave continuous measurement of core vital signs, especially in a small,low power form factor.

SUMMARY

The subject of this invention is focused on the measurement of multipledata streams in a unique optical, electrical, and mechanical device forcontinuous measurement of core vital signs. The approach taken leveragesunique approaches to acquiring multiple data streams with a single smallform factor device. This is possible through the use of a simultaneousfunction electromechanical stack up. This simultaneous stack up allowsfor multiple functions in the same physical space, allowing achievementof a small form factor device, capable of acquiring multiple datastreams simultaneously.

The stack up includes integration of a reflective pulse oximeter,one-lead EKG, resistive heater, a vertical set of thermistors thatmeasure heat radiating from the body, thermistor lens, and adouble-sided adhesive gel pad. At the minimum, the stack up has aprinted circuit board (PCB) that has a one-lead EKG with a reflectivepulse oximeter. This allows for simultaneous measurement of at least twodata streams. The heater and thermistor stack up allow for measurementof heat radiating from the body and a measurement of core bodytemperature to be determined. This adds the third data stream from whichsix core vital signs can be determined: heart rate, respiratory rate,EKG, SpO2, and core body temperature.

The PCB has an EKG chip, reflective pulse oximeter, resistive heater,and thermistors. The layout is arranged so that the resistive heateroverlays the pulse oximeter. This allows for heating the stackupcomprising the following: pulse oximeter, thermistors, and thermistorlens. The use of resistive heating elements onboard the PCB decreasesthe thickness of the unit. Normally, in electrical assemblies, anyheating elements would be a separate layer or component from the mainPCB. The PCB allows measurement of all these parameters on a singleboard.

Core body temperature is measured by heat radiating from the body. Inaddition, the use of a resistive heater on the PCB counteracts the heatradiating from the body, allowing the thermal resistance of the body tobe determined, and thus the core body temperature to be measured. Theuse of more than one thermistor allows the determination of heatradiating from the body. This arrangement allows for accuratemeasurement of the core body measurement.

The stack up includes a thermistor lens, or a precision thermistorembedded in an optical element. The optical element is in contact withthe body skin surface, allowing for good light transmission andsimultaneous thermal contact of the body with the thermistor. Thethermistor lens is custom molded to allow the lens or optical element toachieve two different functions at the same time. In the stack up, thisallows the pulse oximeter to be directly overlayed on top of the corebody temperature thermometer in the same physical and electromechanicalspace.

The adhesive gel pad is double-sided and allows for attachment of thevitals device to the skin. There is a skin side adhesive and a deviceside adhesive. This is clearly identified, by having two differentcolors for the sides. The surface area of the gel pad contact to theelectrodes is sufficient to allow measurement of the body's electricalsignals. There is an aperture in the gel pad that allows direct contactof the thermistor lens to the skin, allowing for optical and thermalcoupling of any signals from the body. The stack up therefore includesthe gel pad, which provides key features for interfacing the skin withthe device.

The mechanical packages positions the EKG electrodes and the pulseoximeter aperture and thermistor lens on one side of the unit, allowingfor simultaneous collection of multiple data streams from theindividuals. Furthermore, the unit provides thermal insulationmaximizing the temperature difference in the thermistors and allowingany unit heating to be retained largely within the device. Theinsulation decreases the power consumption of the unit, allowingcontinuous vitals on a single charge for a longer period of time.

By employing a simultaneous stack up of the electromechanical andoptomechcanical package, multiple functions are achieved in the samephysical space, allowing the overall vitals unit to be small, compact,and capable of measuring multiple vitals streams simultaneously.

BRIEF DESCRIPTION OF DRAWINGS

FIG. 1 shows the top and bottom view of the vitals device. The top viewhas the power button and the bottom of the device is attached to aremovable gel pad that has conductive gel and an aperture for thethermistor lens.

FIG. 2 shows the section view and stack up of the vitals device. Thisaperture in the gel pad allows for contact of the thermistor lens withthe skin. Multiple thermistors allow for measurement of heat radiatingfrom the body. The PCB is integrated to allow measurement of multiplevitals streams.

FIG. 3 shows the side views of the device. Two of the four sides haveLEDs for indicating the status of the unit. The gel pad is evident fromthe side view.

FIG. 4 shows the three-dimensional view of the device with the powerbutton and the LED light.

FIG. 5 shows the front and back of the gel pad. The semi-circularregions contain conductive gel. The aperture in the center allows forthe thermistor lens to touch the skin. Both sides of the gel pad aredifferent colors to allow for clear orientation of the gel pad.

FIG. 6 shows the thermistor lens which has a thermistor embedded in thelens. Leads allow for attachment to the PCB.

FIG. 7 shows the bottom of the vitals device without the bottom cover.The two charging rings are event. The resistors are arranged in a radialmanner to allow for heating of the unit.

FIG. 8 shows a rectangular stack up of the vitals device. This alternatearrangement utilizes conventional electrode pads with snaps.

FIG. 9 shows capture of multiple data streams simultaneously off theunit, including EKG, PPG, and core body temperature.

DETAILED DESCRIPTION

In one embodiment, an octagonal device is utilized to carry all thesensors required for comprehensive vital signs measurements. Theoctagonal device measures approximately 60 mm in diameter and 10 mm inheight. In order to attain this compact form factor and to be able tomeasure multiple vitals streams simultaneously, the sensor stack upneeds to be occupying similar physical space.

In this embodiment, at the center of the PCB is the reflective pulseoximeter surrounded by a radial configuration of resistors. Theresistors serve as a heating element for the system and are in the samephysical plane as the reflective pulse oximeter chip and the mounts forthe EKG electrodes. The method of PCB manufacture is well-known and canbe done via a number of different commercial vendors. A thermistor lensis directly attached to the PCB in the center of the unit. This is doneby molding clear plastic, silicone, or some other optically transparentmaterial for the thermistor lens. The plastic can be polycarbonate,acrylic, clear urethane, or a thermoplastic elastomer. Silicone can beliquid silicone, curable silicone, or some otherwise clear silicone. Theclear material contacts the PCB, encapsulates the reflective pulseoximeter chip, and the thermistor. This stack up creates a singleelement that emits infrared light, red light, measures temperature, andcollects photoplethysmograph signals. Depending on the differentmaterial utilized, the thermistor lens can be injection molded, softmolded, or otherwise attached onto the PCB to ensure a uniform, clearmaterial is in the central portion of the vitals unit.

There are at least two, ideally three to four, high precision (+/−0.1°C.) thermistors in the unit. The thermistors are ideally arranged in avertical stack up configuration, with one in the thermistor lens. Theclear, thermistor lens material should have a low thermal conductivity,ideally less than 0.02 W/(m·K). The insulating nature of the materialminimizes heat loss and increases the flux differential between thethermistors. The device should be sealed to prevent heat loss in thesystem. The outer casing should be insulating and there should be no airgaps that allow heat to escape from the unit. The thermistors measurethe thermal gradient from the body and allows the core body temperatureto be determined with great accuracy. Through the use of the resistiveheater on the PCB, more than one temperature gradient can be attained,allowing determination of the core body temperature.

The vitals pad allows for attachment of the device to the body and forcontinuous monitoring of multiple data streams for the vitals. Thevitals pad has adhesive on both sides of it, allowing attachment to thebody and the device for continuous measurement. The colors of the deviceside and the skin side of the vitals pad are different to allow fororientation of top and bottom for the user. At least one of the colorsshould be dark to prevent external light from reaching the opticalsensor. This allows for The adhesiveness can be adjusted on both sidesdepending on the duration of use. There are two half moon gel padregions on the unit, allowing direct contact of the skin with theelectrically conductive gel pad and then to the EKG electrodes. Thecircular aperture in the center allows the thermistor lens to protrudethrough and be in contact with the skin for good optical and thermalcontact. The vitals pads are designed to be single use and replaced witheach data logging.

There are two EKG electrodes on the unit. These are designed electrodesand also allow for contact with the gel pad for measurement of aone-lead EKG. They are made of gold-plated brass for optimal electricalconduction. Contact with the gel pads allow for conduction of smallelectrical signals from the body into a recognized EKG signal consistingof a P-wave, QRS complex, and T-wave. The one-lead EKG is useful formeasurement of basic electrical activity from the heart. As the heartcontracts and conducts electrical signals, this is measured on thesurface of the body. The ideal attachment location of the vitals deviceis on the chest or sternum, although other area may also give adequatesignal for measurement of a one-lead EKG.

Other types of EKG pads can be possible in other embodiments, such asthe strap embodiment. This utilizes two conventional, off-the-shelf EKGpads with snap hooks that allow for reversible attachment to the sensor.This alternate approach allows for use of traditional electrodes and canbe helpful when ensuring compatibility with existing types of medicaldevices. In all cases, the EKG gel pads should position the thermistorlens so that it is touching the skin for thermal and opticalmeasurements.

There is a power button for actuation of the device. LED indicatorsalert the user as to when it is on and the state of the device (on,measuring data, etc.). Other types of indicators can also be introducedinto the system, including vibratory alerts since the user cannotvisualize the LED indicators during continuous wearing of the device.The alerting indicators allow embedded code on the device to communicatewith the user. For instance if the heart rate is above normal limits,then the device will indicate to the user the possibility of an abnormalevent.

Data is transmitted from the sensor to an app using Bluetooth Low Energy(BLE). This allows for wireless data transmission using minimal batterypower. The PCB has a BLE chip that is on the top side of the PCB, awayfrom the skin. This allows it to be accessible for communications and isnot blocked. The mechanical package is such that it allows enoughclearance for the BLE chip to give adequate communications with theclient BLE device such as a phone or tablet running an app. Onboardmemory, such as flash, allows local data storage when the vitals deviceis not communicating to its BLE client. This allows for continuousdiscontinuous operation where the device can be worn and collecting datawithout the need for a receiving BLE client. Data can be downloaded fromthe onboard memory to another device.

In one embodiment, there are magnetic contacts for charging and datatransfer. In one particular arrangement, the charging contacts forpositive and negative are concentric circles. Placement of the vitalsdevice onto protruding pogo pins on a receiving dock allows recognitionof the vitals device and charging to occur. Three pogo pins arerequired: positive, negative, and sense. In this manner, if only twopins are contacted, no current will be drawn. The concentric chargingrings allow for orientation independent placement of the unit onto thecharging dock. The rings are made of a magnetic material such asstainless steel 430 and magnets are placed on the receiving dock. Inthis manner, the magnets serve to help register the charging rings ontothe pogo pins for correct contact.

High speed data transfer from the vitals device to another device isrequired so that data stored on the device can be readily accessed. BLEhas data limitations so ideally the data transfer mechanism be infrared(IR) or serial data transfer. For IR data transfer, an IR transmitter isembedded in the central thermistor lens with a receiving photodiode onthe dock. This arrangement allows use of the central thermistor lens,adding to the multi-functional stack in the center of the unit. Analternate approach is to utilize metal magnetic contacts for high speedserial or parallel data transfer.

In one embodiment, the device has an octagonal shape. Other shapes maybe possible including rectangular strap form, circular, triangular, orpentagonal. The part integration will be similar in these cases.

Those skilled in the art will recognize, or be able to ascertain usingno more than routine experimentation and/or engineering, manyequivalents to the specific embodiments of the invention describedherein. The scope of the present invention is not intended to be limitedto the above Description, but rather is as set forth in the claims thatfollow.

What is claimed is:
 1. An integrated vitals sensor comprising: areflective pulse oximeter; a plurality of thermistors, comprising atleast one first thermistor and at least one second thermistor, inproximity to the reflective pulse oximeter; and a single lead EKG,wherein the integrated vitals sensor is configured to be in proximity toa wearer's skin and the at least one first thermistor is configured tobe in closer proximity to the wearer's skin than the at least one secondthermistor, such that the plurality of thermistors are configured tomeasure a heat gradient from the direction of the wearer's skin.
 2. Thesensor of claim 1 wherein the reflective pulse oximeter and the singlelead EKG are integrated into a single circuit board.
 3. (canceled) 4.(canceled)
 5. The sensor of claim 3 wherein the reflective pulseoximeter, the single lead EKG, the resistive heater, and at least one ofthe plurality of thermistors are integrated into a single circuit board.6. The sensor of claim 1 further comprising a wireless transceiver. 7.The sensor of claim 6 wherein the wireless transceiver uses BluetoothLow Energy.
 8. The sensor of claim 1 further comprising a double-sidedadhesive gel pad to permit the sensor to be worn in contact with skin.9. The sensor of claim 3 wherein the thermistor is embedded in a lens.10. The sensor of claim 9 wherein the lens is positioned to be incontact with the skin when the sensor is worn in contact with the skin.11. An integrated vitals sensor comprising: a reflective pulse oximeter;a single lead EKG; a first thermistor; a second thermistor, such thatthe first thermistor and second thermistor are configured to measure aheat gradient from the direction of a wearer's skin; and a resistiveheater, wherein at least one thermistor is in communication with theresistive heater.
 12. The sensor of claim 11, further comprising adouble-sided adhesive gel pad to permit the sensor to be worn in contactwith skin, wherein a color of a first side of the adhesive gel pad isdifferent than a color of a second side of the adhesive gel pad.
 13. Thesensor of claim 11, further comprising a double-sided adhesive gel pad,wherein at least a first portion of the gel pad has a dark color that isconfigured to prevent external light from reaching the sensor.
 14. Thesensor of claim 11, further comprising at least one resistive heater,wherein the at least one resistive heater, the single lead EKG, thefirst thermistor, and the reflective pulse oximeter are integrated intoa single circuit board.
 15. The sensor of claim 11, further comprising aplurality of resistors arranged in a radial configuration around thereflective pulse oximeter.
 16. The sensor of claim 11, wherein thesensor is further configured to detect at least one of heart rate,respiratory rate, EKG, and SpO2.
 17. The sensor of claim 11, wherein thereflective pulse oximeter is located between the first thermistor andthe second thermistor.
 18. A method of manufacturing an integratedvitals sensor, the method comprising: providing a reflective pulseoximeter; providing a single lead EKG; providing a first thermistor;providing a second thermistor, such that the first thermistor and secondthermistor are configured to measure a heat gradient from the directionof a wearer's skin; providing a circuit board; providing a resistiveheater; connecting the reflective pulse oximeter, the single lead EKG,the resistive heater, and the first thermistor to the circuit board, theconnection causing electrical contact between the circuit board, thereflective pulse oximeter, the single lead EKG, the resistive heater,and the first thermistor; and positioning the second thermistor, suchthat the second thermistor is in communication with the resistiveheater.
 19. The method of claim 18, further comprising: providing aninfrared transmitter; providing a central thermistor lens; and embeddingan infrared transmitter into the central thermistor lens.
 20. The methodof claim 18, further comprising: providing a plurality of resistiveheaters; connecting the plurality of resistive heaters to the circuitboard, such that the plurality of resistive heaters is connectedradially around the reflective pulse oximeter.